Procedure for sampling and analysis of Raw material and Finished product for microbial analysis

1.0    PURPOSE:

1.1    To lay down a Procedure for sampling and analysis of Raw material and Finished product for microbial analysis

1.0    SCOPE

2.1    This SOP covers the procedure for sampling and analysis of Raw material and Finished product for microbial analysis and is applicable in Microbiology.
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3.0    RESPONSIBILITY:

    3.1     Microbiologist

4.0    ACCOUNTABILITY:    

    4.1    Manager – Quality Control

5.0    PROCEDURE: 

        5.1 Sampling

5.1.1    Sampling shall be done for microbial analysis for regular batches as per SOP XXXXX
5.1.2    Sampling shall be done by microbiologist only for product validation by following the below procedure.
5.1.3    Requirement
5.1.3.1    Sterile Glass bottles / sterile polyethylene bags
5.1.3.2    Sterile Spatula / Sampling Rod
5.1.3.3    Sterile Gloves
5.1.3.4    70 % IPA
5.1.4    Carry all the above items in a sampling kit for sampling.
5.1.5    Shift the containers one by one to the sampling booth for sampling.
5.1.6    Enter in the details the sampling booth register (for raw materials).
5.1.7    Take out the container / bag from the sampling kit and note the Name of the sample, Batch no, Sampling date, Manufacture date, Expiry or retest date, Sampled by and Quantity sampled on the bottle / bag.
5.1.8    Wear the gloves and mask and spray 70% IPA on the gloves and wait until it dry.  
5.1.9    Open it carefully and collect the sample with a spatula or with a Sampling rod.
5.1.10    Similarly carry out the sampling from all the containers of a same batch to get a pool sample of 10 Gms / 30 Gms / required quantity.
5.1.11    During collection of each sample wipe the spatula with 70 % IPA to proceed for next sample.
5.1.12    After sampling bring the sampled bottles to the microbiology lab and carry out the analysis with in 2 hours from the time of sample collection or store in a refrigerator and carry out with in 24 hours.

5.2    Analysis 

5.2.1    Issue the Analytical worksheet on the date of sampling to enter the details of analysis.
5.2.2    Carry out the analysis as per current version of GTP No’s 201,202,203, 204, 206,212,213,214,215,216&217.

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Procedure, microbiology, raw material, microbial analysis